# K202237: Locking device

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou AGS MedTech Co., Ltd.
- Decided: Dec 23, 2020 after 138 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970054 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040137: Wilson-Cook Usw Cap and Wire Lock, Wilson-Cook Medical, Inc. (2004) Summary page 4.

## Indications for use
This device is an accessory to be used with endoscopic biliary devices to lock the guidewire(s) in place during ERCP procedure. The device is supplied sterile and intended for single use only.

Source page: https://510kreport.com/device/K202237
Methodology: https://510kreport.com/methodology